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Completed

NCT Number: NCT04818450

Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient

The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

About this study

Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (18 years and older)
  • Patients admitted to ICU not more than 24 hours at the time of randomization

Exclusion criteria

  • Patients admitted to ICU less than 72 hours
  • Patients receiving gabapentin within 14 days prior to randomization
  • Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization
  • Patients having contraindications to gabapentin
  • Patients receiving high dose vasopressors more than 1 hour during ICU admissions
  • Patients presenting with severe respiratory failure (PF ratio < 100)
  • Patients presenting with RASS < -2 at the time of randomization
  • Patients having target RASS of <-2 during ICU admissions
  • Terminal ill patients
  • Pregnancy

Treatment and study plan

Gabapentin

Drug

Gabapentin 100-300 mg is given to the intervention group

Other names: Gabapentin group

Primary outcomes

  1. Slow-wave sleep

    Time frame: at least 3 consecutive days after randomization

    Slow-wave sleep period or deep sleep period

Secondary outcomes

  1. All-cause hospital mortality

    Time frame: During hospital stay or death or a maximum of 90 days

    Rates of all-cause mortality during hospital stay

  2. ICU free days

    Time frame: During ICU stay or death or a maximum of 28 days

    Days alive and not stay in ICU

  3. Mechanical ventilator free days

    Time frame: During ICU stay or death or a maximum of 28 days

    Day alive and free of mechanical ventilator

  4. Hospital free days

    Time frame: During hospital stay or death or a maximum of 90 days

    Days alive and not stay in hospital

  5. Incidence of self-extubation

    Time frame: During ICU stay or death or a maximum of 28 days

    Number of patients who had self-extubation during ICU stay

  6. Incidence of sleep deprivation

    Time frame: During ICU stay or death or a maximum of 28 days

    Times per patient-days of sleep deprivation during ICU stay

  7. Delirium free day

    Time frame: During ICU stay or death or a maximum of 28 days

    Days alive and not having delirium

Other outcomes

  1. IGF-1

    Time frame: At day 0, 1, 3, and 5 after randomization

    IGF-1 level

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.

Acronym: GASWAC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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